Director of Quality

4 weeks ago

Columbus, United States STAQ Pharma Full time

STAQ is currently hiring for a Quality Director to join our team here in the Columbus area.

About Us: STAQ Pharma is a fast-growing pharmaceutical company specializing in 503B outsourcing manufacturing, established in 2017 in Denver, CO. We are committed to delivering high-quality, safe, and compliant products to our clients. As we expand, we are seeking an experienced Quality Director to join our team in Columbus, OH and play a pivotal role in ensuring our quality standards meet and exceed industry regulations.

Job Summary: The Director of Quality will oversee all aspects of quality management, including batch records, batch review, batch release, and deviation investigation. The ideal candidate will have a strong background in cGMP and preferably experience in a 503B outsourcing pharmaceutical manufacturing facility.

Key Responsibilities: In this role, you will develop and implement a comprehensive Quality Management System (QMS) that aligns with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. You will provide strategic direction and leadership to the quality team, ensuring adherence to established quality objectives, policies, and procedures. Your responsibilities will also include overseeing the management of batch records, ensuring accurate documentation, review, and release processes are followed, as well as leading and supporting investigations into deviations, out-of-specification results, and customer complaints, with a focus on implementing effective corrective and preventive actions.

Maintaining up-to-date knowledge of relevant regulations and industry guidelines is critical to this role, as you will be responsible for ensuring compliance with FDA, State Boards of Pharmacy, and other regulatory agencies. Additionally, you will serve as the primary point of contact for regulatory agencies, leading inspections and audits, and ensuring timely and accurate responses to regulatory inquiries. Collaboration with cross-functional teams, including manufacturing, R&D, regulatory affairs, and supply chain, will be essential to ensure quality processes are integrated throughout the product lifecycle. You will also monitor key quality performance indicators (KPIs) and drive continuous improvement initiatives to enhance product quality and compliance.

Qualifications:

  • Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field. An advanced degree (e.g., Pharm.D., Ph.D.) is preferred.
  • 2-5 years of experience as a Quality Director, with a strong background in cGMP and quality assurance within the pharmaceutical industry.
  • Proven experience in batch records, batch review, batch release, and deviation investigations.
  • Preferably, experience in a 503B outsourcing pharmaceutical manufacturing facility.
  • Strong knowledge of FDA regulations, ICH guidelines, and other relevant quality standards.
  • Demonstrated success in managing regulatory inspections and audits.
  • Excellent leadership, communication, and problem-solving skills.
  • Ability to adapt to a fast-paced, evolving environment and manage multiple priorities.

Why Join Us? At STAQ, you’ll have the opportunity to make a significant impact in a growing company. We offer a collaborative and supportive work environment, competitive compensation, and the chance to advance your career.

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